Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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KIT, OPTIGEN US Food 25
Minaris Medical America, Inc.
85066
In Commercial Distribution

  • 00813382010440 ()
85066

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 25 (100 ND)
Minaris Medical America, Inc.
85082
In Commercial Distribution

  • 00813382010433 ()
85082

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Inhalant 36 (100 ND)
Minaris Medical America, Inc.
85081
In Commercial Distribution

  • 00813382010426 ()
85081

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Mix 36
Minaris Medical America, Inc.
85065
In Commercial Distribution

  • 00813382010396 ()
85065

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 20
Minaris Medical America, Inc.
85064
In Commercial Distribution

  • 00813382010389 ()
85064

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Inhalant 36
Minaris Medical America, Inc.
85063
In Commercial Distribution

  • 00813382010372 ()
85063

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
Kit, Southern
Minaris Medical America, Inc.
84508
Not in Commercial Distribution

  • 00813382010334 ()
84508

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Moderate Food
Minaris Medical America, Inc.
84518
In Commercial Distribution

  • 00813382010174 ()
84518

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Western Inhalant
Minaris Medical America, Inc.
84511
Not in Commercial Distribution

  • 00813382010167 ()
84511

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Southwestern Inhalant
Minaris Medical America, Inc.
84509
Not in Commercial Distribution

  • 00813382010150 ()
84509

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Southeastern Inhalant
Minaris Medical America, Inc.
84507
In Commercial Distribution

  • 00813382010143 ()
84507

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Pediatric Comprehensive
Minaris Medical America, Inc.
84506
Not in Commercial Distribution

  • 00813382010136 ()
84506

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Northwestern Inhalant
Minaris Medical America, Inc.
84505
Not in Commercial Distribution

  • 00813382010129 ()
84505

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Northeastern Inhalant
Minaris Medical America, Inc.
84504
In Commercial Distribution

  • 00813382010112 ()
84504

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, Eastern
Minaris Medical America, Inc.
84502
In Commercial Distribution

  • 00813382010105 ()
84502

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN® Environmental 36 (20T)
Minaris Medical America, Inc.
85068
In Commercial Distribution

  • 00813382010037 ()
85068

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 30 (100ND)
Minaris Medical America, Inc.
85267
In Commercial Distribution

  • 00813382010020 ()
85267

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN® Food 29 (20T)
Minaris Medical America, Inc.
85067
In Commercial Distribution

  • 00813382010013 ()
85067

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
No Description
HYCOR BIOMEDICAL LLC
K332065-2
In Commercial Distribution

  • 00816879028881 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K33218085-4
In Commercial Distribution

  • 00816879028850 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332030-2
In Commercial Distribution

  • 00816879028836 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332020-2
In Commercial Distribution

  • 00816879028829 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63125
In Commercial Distribution

  • 00816879023251 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63180
In Commercial Distribution

  • 00816879023077 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63145
Not in Commercial Distribution

  • 00816879023015 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332065-2Z
In Commercial Distribution

  • 00816879029642 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332030-2Z
In Commercial Distribution

  • 00816879029635 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332020-2Z
In Commercial Distribution

  • 00816879029628 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63180Z
In Commercial Distribution

  • 00816879029550 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63125Z
In Commercial Distribution

  • 00816879029499 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K33218085-4Z
In Commercial Distribution

  • 00816879029468 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
74155
Not in Commercial Distribution

  • 00816879022308 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
ImmunoCAP Allergen Ri204, Horse fly
Phadia AB
14-5207-10
In Commercial Distribution

  • 07333066008387 ()
14-5207-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rf312, Swordfish
Phadia AB
14-5205-10
In Commercial Distribution

  • 07333066008349 ()
14-5205-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rf311, Megrim
Phadia AB
14-5204-10
In Commercial Distribution

  • 07333066008325 ()
14-5204-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen Rt209, Horn beam
Phadia AB
14-5148-10
In Commercial Distribution

  • 07333066007618 ()
14-5148-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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